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TERMINATED
NCT00788307
PHASE1

Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to Radiation Therapy

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine. PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to definitive radiation therapy.

Official title: Phase I Trial of In Situ Gene Therapy for Locally Recurrent Prostate Cancer Following Radiation Therapy Failure Using Sodium/Iodide Symporter and Radioiodine

Key Details

Gender

MALE

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2008-11-03

Completion Date

2018-02-07

Last Updated

2026-07-22

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Ad5-CMV-NIS

Given intraprostatically

DRUG

Liothyronine Sodium

Given PO

GENETIC

Reverse Transcriptase Polymerase Chain Reaction

Peripheral blood cells (20 ml of plasma collected in two CPT tubules) will be evaluated for evidence of virus DNA

OTHER

laboratory biomarker analysis

Correlative study

RADIATION

Iodine I 131

Given PO

RADIATION

Iodine I 123

Given PO

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States